non-small cell lung cancer
Conditions
Interventions
Experimental group:Sequential carrelizumab maintenance treatment after concurrent radiotherapy and chemotherapy
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The researcher judges that continuing the research and treatment is in the best interests of the subjects, and the subjects do not need to start other anti-tumor treatments immediately; 2. The subject's ECOG score is 0 or 1, and can tolerate the study treatment; 3. If the functions of main organs are normal, patients need to meet the following hematological indicators: (1) blood routine examination: HB >= 90 g/L; ANC >= 1.5×10^9/L; PLT >= 60×10^9/L; (2) biochemical examination: ALB >= 2^9 g/L; ALT and AST = 20%); 9. The curative effect information can be collected according to the RECIST 1.1 standard for the curative effect evaluation standard of solid tumors, and the measurable lesions that can be examined by CT or MRI; 10. Patients voluntarily join this study, all need to sign an informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have any active, known or suspected autoimmune diseases, or systemic immunosuppressive treatments are not allowed to be included in the group; 2. Exclude patients who are highly suspected of having interstitial pneumonia; or patients who may interfere with the detection or treatment of suspected drug-related lung toxicity; 3. Patients with active tuberculosis should be excluded. Patients who are suspected of having active TB should be checked for chest X-ray, sputum, and excluded through clinical symptoms and signs; 4. Patients with intracranial tumors, brain trauma, and medications that may cause brain edema should be excluded; 5. Patients with EGFR mutation or ALK fusion positive; 6. Patients was diagnosed with immunodeficiency or received systemic hormone therapy (for example, hormone therapy equivalent to > 10mg prednisone per day) within 14 days before the first administration, or used any other form of immunosuppressive therapy; Note: If the subject does not suffer from active autoimmune diseases, hormones equivalent to <= 10 mg of prednisone per day are allowed as adrenal replacement therapy. Subjects are allowed to use topical, ophthalmic, intra-articular, intranasal and inhaled corticosteroids (very low systemic absorption). Allows the use of short-term glucocorticoids for prevention (for example, contrast agent allergy) or treatment of non-autoimmune diseases (for example, delayed type hypersensitivity caused by contrast agent allergy). 7. Other primary malignant tumors appear within 5 years, except for locally curable malignant tumors that have undergone radical treatment (except for basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast, etc. ); 8. Grade 2 pneumonia caused by radiotherapy and chemotherapy (Grade 2 pneumonia that has not been treated with systemic hormones returns to grade 1 or below within 14 days, with interstitial lung disease and symptoms of the disease; the investigator believes that the previous history of lung disease may be Subjects who interfere with the judgment or treatment of drug-related pulmonary toxicity also need to be excluded; 9. Subjects with a history of active pulmonary tuberculosis infection within 1 year, and a history of active pulmonary tuberculosis infection more than 1 year ago, if the investigator judges that there is no evidence of active pulmonary tuberculosis, they are considered suitable for inclusion; 10. A history of inflammatory bowel disease or current inflammatory bowel disease (such as Crohns disease and ulcerative colitis); 11. Patients with known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome; 12. Subjects with active chronic hepatitis B or active hepatitis C. Subjects who are positive for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody during the screening period must pass the hepatitis B virus (HBV) DNA titer test (exclude more than 2500 copies [cps ]/mL or 500 IU/mL) and HCV RNA testing (excluded from exceeding the lower limit of detection of the assay), after excluding active hepatitis B or hepatitis C infection requiring treatment, can be included in the group. Carriers of hepatitis B virus, hepatitis B that is stable after drug treatment (DNA titer shall not be higher than 2500 copies [cps]/mL or 500 IU/mL) and cured hepatitis C subjects can be included in the group; 13. Suffered from an active
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival rate (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Objective response rate (ORR);Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactHong Liu
Qilu Hospital of Shandong University
Outcome results
None listed